1. Field of the Invention
The present invention relates to the field of ostomy devices, and, more particularly, to a self-retaining ostomy port which can be installed into a stoma and secured for long-term placement without the use of adhesives, belts, bandages or revisionary surgical measures, and thus allows the user to be effectively xe2x80x9ccontinentxe2x80x9d. The new ostomy port features a low profile and can be repeatedly selectively opened and closed without removal from the stoma, as may be necessary or desired by the individual user, and does not require the constant attachment of an ostomy bag or pouch.
2. Background of the Invention
Surgically formed stomas may be of a variety of types, including, but not limited to, ileostomies, colostomies and urostomies. Although the discussion below will usually describe the invention with reference to the stoma resulting from a colostomy procedure, it is to be understood that the new continent ostomy port can be applied to other types of stomas as well, including those interfacing with internal reservoirs. It will further be appreciated in view of the disclosure herein that many of the various embodiments of the bolster portion of the new continent ostomy port can also be usefully applied to other known types of medical catheters, such as urinary catheters, endotracheal tubes, and the like, for example. For simplicity of discussion, however, the following usually discusses the new device in terms of use with or as an ostomy port device. The structure and use of the new device and portions thereof, are not to be considered limited by such discussion, as will be made clear throughout.
Ostomates, individuals provided with a stoma, have historically been faced with a variety of problems not ordinarily experienced by the general (non-stoma bearing) public. These problems have included seepage of intestinal gas and waste, such as mucous and liquid and solid fecal material from around the site of the stoma. Such seepage not only causes unpleasant and embarrassing odors, but also leads to health problems, such as necrosis of the tissue surrounding the stoma site, creating the additional problems of increased expense and health risks related to further surgery to relocate or modify the existing stoma.
Traditional ostomies generally require the patient to have a bag or container of some sort attached to the ostomy for constant collection of body waste. Necessarily, the bag will become heavy and cumbersome as it automatically fills with body waste over time, and the user is faced with the. risk of spillage. from the bag, while in place, as. well as during the process of emptying the bag.""s contents. Further, the material of the bag (as well as some adhesives) can cause allergic reactions in some users, and the bag material also makes bothersome noises during movement as the bag rubs against the user""s clothing. For many ostomates, the bulk of the bag beneath clothing is also a problem. All these aspects of having an ostomy can deter social activities of all types, and especially any which are relatively more physical in nature. Frequently isolation and depression result.
The known art has made a variety of attempts to address these problems, without complete success. Although the majority of ostomates use bags to manage the ostomy excretions, a number of barrier devices have been developed which essentially plug or seal the stoma until the user is ready to purge, with resultant problems further discussed hereafter, which were not clinically viable, and in many cases, have necessitated. revisionary surgery. By contrast, the new continent ostomy port is just that, a port, not a sealed closure or plug. Rather, constant but gradual, filtered, controlled venting of intestinal gas is provided with the new port, relieving the user from discomfort of internal pressure build-up. The new device also permits quick and facile access for irrigation and purging the ostomy without removing the port from the stoma, by use of specially designed adaptors in combination with the new COP, for example, to connect a gravity bag by tubing to the COP.
One such previous device included strong magnets in the external portion of the closure and magnets surgically sealed within the user""s skin for transdermal connection of the ostomy plug-type closure. Leakage and skin irritation can result from use of such a device. Alternatively, if the plug is too tight, an extremely uncomfortable, even painful, build-up of intestinal gasses can occur. Known stoma closure or plugging systems also suffer, inter alia, from the problem of not being adjustable in response to daily variations in the user""s body, as well as variations between user""s tissues; i.e., they are not xe2x80x9cbioresponsivexe2x80x9d, so that in order to install the device in a manner sufficient to maintain a fluid-tight seal, the tissue around the stoma is severely. pinched, obstructing blood flow. The loss of blood eventually causes. tissue death and results in further surgery being required to remove the damaged tissue and .to repair the stoma. Some other devices are difficult to clean and therefore permit waste to accumulate in crevices, resulting in unpleasant odors and tissue irritation. All of these shortcomings of the art are addressed by the various embodiments of the new continent ostomy port.
When a stoma is tightly sealed for an extended period, such as a matter of hours, there can be a painful build-up of intestinal gasses, which are explosively released as a bolus when the stoma seal is breached. Previous attempts to filter such gasses have met with limited success, as the filter device could permit leakage to occur. Known devices also do not take into account adjustment or adaptability to account for pouch disturbances, which occur due to internal or external pressure changes. The new continent ostomy port has a number of structural. features such as the new bolster concepts that permit it to overcome these and other disadvantages of the known art.
The new continent ostomy port described herein can be non-surgically installed into a new stoma or non-surgically retrofit into a patient who has an existing ostomy, and provides the ostomate with greater freedom of movement without the untoward results often associated with use of conventional devices. The new ostomy port permits long-term (at least 29 days) port access and eliminates the need to. continuously wear an ostomy bag and/or the need for lengthy daily irrigation procedures. This long-term access port prevents the leakage sometimes associated with the use of irrigation devices and colostomy bags because the connection between such ostomy accessories and the patient is via the new locking, sealing port. Conventionally such accessories are connected directly to the stoma site by gluing or belts, thus permitting leakage because a complete seal at the site of connection is not always possible. Thus, for example, when irrigating by the. conventional method the ostomate must carefully manually retain the irrigation tube connected to a cone in the stoma while introducing. fluids from a gravity bag in order to prevent spillage. Now the user of the new COP can connect a gravity bag via tubing adapted with connectors disclosed herein which are designed specifically for liquid-tight attachment to the COP and can then introduce irrigation fluid while having both hands free for other activities such as applying make-up or shaving.
In view of the various short-comings of the known art, it is among the several goals and advantages of the present invention to provide a continent ostomy port (xe2x80x9cCOPxe2x80x9d) i.e. a port which permits the ostomate to be effectively continent, which virtually eliminates leakage of liquid and solid waste from the stoma, and which continuously controls gaseous odors by permitting gradual filtered release of intestinal gasses. The new device, having the features mentioned, is adapted to be selectively connected to a pouch or tubes, as may be necessary from time to time to dispose of waste and to irrigate the intestine for cleanliness and health, while also being capable of being tightly capped for substantial periods of time, even hours, for example, to permit the user to engage in normal physical activities and to function in a wide variety of social settings without fear of accident or embarrassment.
Because an external pouch is not required to be worn, and there are no belts, adhesives or other additional devices required to hold the new COP securely in place, the user has the freedom to wear tighter or more-revealing clothing than would otherwise be possible, and there is no concern of noises, such as xe2x80x9ccrinklingxe2x80x9d sounds, inherent with the usual plastic ostomy bags. The user thus is provided with a generally improved quality of life, including enhanced body image, increased confidence and potential sexuality, and has available a wider potential range of movement, enhancing possible athletic activities as well, without the psychological stress of concerns with leakage and odor. The new device is, however, adapted for selective use with new, specially designed, drain tubes, irrigation sets and optionally biodegradable, disposable waste bags, as well as with known styles of drainage tubes. In addition, the device works with known internal surgically created reservoirs, such as those generally known as Kock and Indiana-type pouches. It is also suitable for use with surgically formed urinary and bowel ostomies, as well as with colostomies, and gastrostomies, and for decompression and irrigation purposes.
It is further among the advantages of the new invention, having the features indicated, that because. of the presence of the catheter portion of the new device in the stoma, there is reduced likelihood of stoma prolapse to the outside of the abdomen, as well as reduced incidence of stoma retraction into the abdomen, and reduced likelihood of strictures in the stoma. There is the further advantage that there is no peristomal skin trauma from heavy colostomy bags and irritating adhesives, and the expense and bother inherent with use of pastes, glues, tapes and belts ordinarily required to keep a conventional stoma and pouch in proper placement is virtually eliminated. The skin to port seal developed in use of the continent ostomy port described herein is not impacted by cutaneous mucous discharge or topographical changes of the user""s body due to weight gain, weight loss or aging, for example. An improved seal and compatibility with irregularly shaped or contoured stomas is readily accomplished with the new COP as compared with the art. Such improved sealing is seen even with use of the new device in ostomate patients who are elderly or obese, with soft or flaccid abdomens. Embodiments of the new ostomy port include customized bolsters, bolsters of irregular/asymmetric shapes and bolsters which can adapt their shapes to accommodate. changes in the body of the user. Further, the new ostomy port can be provided with a bolster portion disclosed. here in a variety of forms, which bolster permits facile removal and replacement with new ostomy ports of increasingly larger sizes.
The indwelling nature of the new COP also has advantages for use in neonates or small children, because the neonate""s skin is especially sensitive to the adhesives conventionally used for attaching a bag or sealing a stoma. The neonate is also well served by the lack of necessity for the constant presence of a colostomy pouch, because of the sheer bulk of the pouch that may overwhelm the tiny infant, literally inhibiting movement. The indwelling nature of the new COP is also ideal for ostomates who are undergoing skin-grafting, providing reduction in the otherwise high incidences of peristomal hemation and/or necrotizing enterocolitis (xe2x80x9cNECxe2x80x9d) seen in such individuals when fitted with conventional stoma pouch devices, because of the difficulties caused by the stoma environment, a surgical wound formed in the patient""s abdominal muscle and the stapled skin over such an opening.
Thus, in furtherance of the above-mentioned goals and advantages, the present invention is, briefly; a continent ostomy port device having a face plate defining a selectively sealable aperture which is formed through and is alignable with the opening of a stoma formed in the body of a user of the device when the face plate of the device is disposed substantially parallel to the body wall of the user, over the site of the stoma, to thereby provide access to the inside of the stoma. A closure portion is connectable or connected to the face plate adjacent to the aperture and is adapted to permit selective and repeatable covering and uncovering of the aperture in the face plate. A catheter portion of the device has a first end and a second end, the first end being connected to and extending from one side of the face plate. The catheter portion extends proximally and the second end of the catheter portion is disposed interior of the user""s body, within the ostomy site when the port device is in normal use position. The catheter portion has. a continuous and exterior side wall, and a continuous interior side wall defining a major lumen, which extends continuously from the aperture in the face plate to the second end of the catheter portion. The catheter portion is sized and shaped appropriately for non-surgical installation through a stoma to a sufficient distance that the presence of the catheter portion within the stoma provides a physical barrier which reduces the incidence of stoma prolapse, without the use of extraneous, externally applied materials or additional surgery. A retaining structure is connected to the catheter of the port device or other medical catheter, and is non-surgically, snugly fittable into the stoma, and thereby causes the port device or other medical catheter to which it is connected to be self-retaining in a normal use position within a stoma of the user, without the need for special surgery and extraneous, external fixation materials such as tape, belts, and adhesives.
The invention further includes, briefly, a removable cartridge that is sized and shaped to fit snugly and slideably within the major lumen of the catheter portion of the. device to thereby prevent inadvertent escape of body waste material form the stoma through the device when the cartridge is in place, so that the user is not required to wear an ostomy bag, and to further thereby clean the. interior side wall of the catheter portion as the cartridge is pressed into the major lumen of the catheter.
The invention also includes, briefly, as selectively operable anti-reflux valve that is attached to the second end of the catheter portion to thereby permit blockage of the major lumen of the catheter portion by activation of the anti-reflux valve when it is desired to prevent escape of body waste through the port device, and to permit passage of fluid or solid material through the port device when the anti-reflux valve is deactivated.
These and other advantageous features of the present invention will be in part apparent and in part pointed out herein below.